Cleared Traditional

K002059 - AMT SPINAL SYSTEM

K002059 is an FDA 510(k) clearance for AMT SPINAL SYSTEM, manufactured by Micron Precision Engineering, Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K002059 · Micron Precision Engineering, Inc. · Orthopedic device
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Nov 2000
Decision
130d
Days
Class 2
Risk

K002059 is an FDA 510(k) clearance for the AMT SPINAL SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Micron Precision Engineering, Inc. (San Pedro, US). The FDA issued a Cleared decision on November 13, 2000 after a review of 130 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Micron Precision Engineering, Inc. devices

FDA 510(k) Submission Details - K002059

510(k) Number K002059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2000
Decision Date November 13, 2000
Days to Decision 130 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 122d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWP Device Classification - Class 2, Special Controls

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - KWP Appliance, Fixation, Spinal Interlaminal

All 368
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K002059.
PARSFIX CABLE-SCREW SYSTEM
K003351 · Spinal Concepts, Inc. · Jan 2001
ISOLA CLOSED DUAL ROD CONNECTOR
K003822 · Depuyacromed · Jan 2001
SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM
K002733 · Depuyacromed · Dec 2000
SIMPLICITY SPINAL SYSTEM
K002103 · Medtronic Sofamor Danek USA, Inc. · Nov 2000
MODIFICATION TO ISOBAR SPINAL SYSTEM
K002959 · Encore Orthopedics, Inc. · Oct 2000
SPEEDLINK TRANSVERSE CONNECTOR
K002082 · Spinal Concepts, Inc. · Oct 2000